The FDA has approved DaTscan (Ioflupane I 123 Injection, from GE Healthcare) for use with single photon emission computed tomography (SPECT) imaging, for the detection of dopamine transporters (DaT) in the brains of adult patients with suspected Parkinsonian syndromes. DaTscan is a schedule C-II controlled substance radiopharmaceutical imaging agent that works by binding to DaT in the brain. A specific marker for DaT, DaTscan produces images that provide visual evidence of the presence of dopamine transporters. DaTscan may be used as an adjunct to other diagnostic evaluations to help differentiate essential tremor from tremor due to Parkinsonian syndromes, but DaTscan cannot differentiate between the different types of Parkinsonian syndromes.

This approval was based on two Phase 3 clinical trials confirming the efficacy of DaTscan for the visualization of DaT distribution within the striata. These studies, evaluating 284 adult patients with tremor, demonstrated the consistent performance of DaTscan in the visual detection of DaT distribution in the brain when compared with a reference clinical diagnosis.

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